Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

From February 2002 to May 2006, youth were screened at four academic sites: University of North Carolina at Chapel Hill, McLean Hospital and Cambridge Health Alliance at Harvard Medical School, University of Washington, and Case Western Reserve University.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

We are referring to the population of participants who had baseline assessment, took at least one dose of trial medication, and had at least one post-baseline assessment. There were 3 randomized subjects, on in each treatment group, who did not take at least one dose of study medication and are not included.

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks

Measure Description

Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.

Time Frame

8 weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Reporting Groups

Description

Olanzapine

oral olanzapine 5-20mg per day for up to 52 weeks

Risperidone

oral risperidone 0.5mg to 6mg daily for up to 52 weeks

Molindone

oral molindone from 10-140mg/daily for up to 52 weeks

Measured Values

Olanzapine

Risperidone

Molindone

Number of Participants Analyzed
[units: participants]

35

41

40

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks
[units: units on a scale]Mean (Standard Deviation)

-26.6
(17.8)

-23.7
(25.5)

-27.0
(17.7)

Statistical Analysis 1 for Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks

Groups [1]

All groups

Method [2]

Mixed Models Analysis

P Value [3]

0.05

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

No text entered.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

Time Frame

8 weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.

Time Frame

8 weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No statistical analysis provided for Change From Baseline in PANSS Negative Symptom Subscale at Week 8

4. Secondary:

Change From Baseline in Weight at Week 8 [ Time Frame: 8 weeks ]

Measure Type

Secondary

Measure Title

Change From Baseline in Weight at Week 8

Measure Description

change in weight from baseline to week 8 in kg

Time Frame

8 weeks

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.

Time Frame

8 weeks

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.

Time Frame

8 weeks

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The most significant weakness of this study was the sample size, which was sufficient only to detect large differences across the three treatments and limited our ability to identify predictors of response or adverse effects.